FDA product code PEG: Nucleic Acid Quantitation Kit
PEG is the FDA product code for nucleic acid quantitation kit. It is a Class I device, regulated under 21 CFR 862.2310 and reviewed by the Clinical Chemistry panel. Devices under PEG reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
A nucleic acid quantitation kit consists of a nucleic acid stain (e.g., fluorescent, colorimetric, etc.) which is used to detect and quantitate small amounts of DNA, RNA, or oligonucleotides in solution by measuring the amount of fluorescence or absorbance at a specified wavelength.
Classification
| Field | Value |
|---|---|
| Device name | Nucleic Acid Quantitation Kit |
| Device class | Class I |
| Regulation | 21 CFR 862.2310 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for PEG devices
openFDA lists no recalls for product code PEG.
Frequently asked questions
What is FDA product code PEG?
PEG is the FDA product code for nucleic acid quantitation kit. It is a Class I device, regulated under 21 CFR 862.2310 and reviewed by the Clinical Chemistry panel.
What device class is PEG?
Class I, regulation 21 CFR 862.2310. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PEG
- Run a recall and safety report across every PEG manufacturer
- Watch product code PEG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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